Product Code: FWZ FDA class 1 21 CFR 878.4950

Operating Room Accessories Table Tray

General, Plastic Surgery

An operating room accessories table tray is a convenience kit containing a combination of accessories and components used alongside operating room tables, packaged together for procedural convenience. It is classified as FDA Class 1 (lowest risk), regulated under 21 CFR 878.4950, within the General, Plastic Surgery medical specialty. Per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this type of convenience kit is under enforcement discretion and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

162

Registration Numbers

162

Unique Applicants

Years Active

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Basic Information

Product Code: FWZ
Device Class: FDA class 1
Regulation Number: 878.4950
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 7

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K960019	RETRACTOR ARM CLAMP	Feb 09, 1996	Substantially Equivalent	Biopsys Medical, Inc.
K945415	'LIL MAC ACCESSORY CLAMP(TM)	Nov 22, 1994	Substantially Equivalent	D.L. Nelson and Assoc., Inc.
K944779	CARBON LIGHTS HAND SURGERY TABLE	Oct 14, 1994	Substantially Equivalent	Allen Medical Systems, Inc.
K935381	KAPS POSITIONING ARM	Apr 15, 1994	Substantially Equivalent	Andronic Devices, Ltd.
K931037	WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)	Jul 30, 1993	Substantially Equivalent	Whitmore Ent., Inc.
K926225	SPONGE COUNTER	Mar 05, 1993	Substantially Equivalent	American Medical Manufacturer, Inc.
K925035	MIDKIFF GEOSTATIC CLAMP	Feb 18, 1993	Substantially Equivalent	D.L. Nelson and Assoc., Inc.
K905565	LATERAL BUTTRESS SUPPORT	Feb 21, 1991	Substantially Equivalent	Mcconnell Orthopedic
K905564	PREP AND OPERATING STAND	Feb 21, 1991	Substantially Equivalent	Mcconnell Orthopedic
K910031	PARK CITY SHOULDER POSITIONER	Jan 24, 1991	Substantially Equivalent	Orthopedic Systems, Inc.
K904826	TKO TELESCOPING LITHOTOMY STIRRUP	Oct 31, 1990	Substantially Equivalent	D.L. Nelson and Assoc., Inc.
K897028	LINCOLN MILLS FOOT AND LEG HOLDER	Jan 12, 1990	Substantially Equivalent	Lincoln Mills, Inc.
K893969	DECUBITUS CARE PAD	Jul 14, 1989	Substantially Equivalent	Gulftrade Exim, Inc.
K890501	SECOND ASSISTANT	Feb 10, 1989	Substantially Equivalent	3M Company
K885215	LINCOLN MILLS HIP HOLDER	Jan 13, 1989	Substantially Equivalent	Lincoln Mills, Inc.
K884928	FREE ARM(TM)	Dec 15, 1988	Substantially Equivalent	Faro Medical Technologies, Inc.
K882078	SPINAL SURGERY FRAME	Jun 16, 1988	Substantially Equivalent	Karlin Technology, Inc.
K880265	WEHBE ARM HOLDER	Feb 18, 1988	Substantially Equivalent	Orthopedic Systems, Inc.
K873139	VARUS AND VALGUS LEG HOLDER	Sep 16, 1987	Substantially Equivalent	Leonard Medical, Inc.
K873370	ALLEN MALLEABLE ANESTHESIA SCREEN	Sep 11, 1987	Substantially Equivalent	Edgewater Medical Equipment Systems
K872900	THE PORTABLE ORDERLY	Aug 21, 1987	Substantially Equivalent	Edgewater Medical Equipment Systems
K871840	MCCONNELL ORTHOPEDIC ANKLE POSITIONER	May 26, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871839	MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT	May 26, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871824	MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM	May 26, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871823	MCCONNELL ORTHOPEDIC TIBIAL POSITIONER	May 26, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871822	MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY	May 26, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871821	MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT	May 26, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871820	MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT	May 26, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871819	MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER	May 22, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871805	MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT	May 19, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871804	MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY	May 19, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871803	MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP)	May 19, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871703	MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM	May 19, 1987	Substantially Equivalent	Mcconnell Orthopedic
K871225	HAND SURGERY TABLE EXTENSION	Apr 07, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K870104	RADIOLUCENT TABLE EXTENSION	Feb 06, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K870101	CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION	Feb 06, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K870098	LITHOTOMY HOLDERS	Feb 06, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K865024	ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER	Jan 12, 1987	Substantially Equivalent	American Container Technology, Inc.
K864881	ARTHROSCOPIC ANKLE HOLDER	Dec 29, 1986	Substantially Equivalent	Orthopedic Systems, Inc.
K864880	COLLINS POSITIONING DEVICE	Dec 29, 1986	Substantially Equivalent	Orthopedic Systems, Inc.
K864459	RAIL CLAMP EXTENSION PIECE	Dec 01, 1986	Substantially Equivalent	American Container Technology, Inc.
K860446	C ARM SURGICAL TABLE	Mar 10, 1986	Substantially Equivalent	Medi-Mech, Inc.
K842700	BASILDON-GARDNER SPINAL FRAME	Sep 12, 1984	Substantially Equivalent	Downs Surgical , Ltd.
K840684	FPP ARMBOARD STRAP	Apr 23, 1984	Substantially Equivalent	Fpp, Inc.
K840422	DEVON HEAD REST	Mar 12, 1984	Substantially Equivalent	Devon Industries, Inc.
K840421	ULNAR NERVE PROTECTOR	Mar 12, 1984	Substantially Equivalent	Devon Industries, Inc.
K833624	SHUTT UNIVERSAL STRESS POST	Nov 28, 1983	Substantially Equivalent	Concept, Inc.
K832472	ELEVATOR CUSHION	Sep 20, 1983	Substantially Equivalent	Inmed Corp.
K830272	PROTET HOLDERS-BLOCKS & ROLL	Jun 03, 1983	Substantially Equivalent	Ritmed, Inc.
K830707	ACUFEX UNIVERSAL LEG HOLDER	May 02, 1983	Substantially Equivalent	Acufex Microsurgical, Inc.
K830612	CHEMO-TABLE	Mar 29, 1983	Substantially Equivalent	Fabrications Unltd.
K821933	OMNISURG SIDE MOUNTING CLAMP & RAIL EXT.	Jul 08, 1982	Substantially Equivalent	Polamedco, Inc.
K821029	ARTHROSCOPY SYSTEM LEG HOLDER	Apr 29, 1982	Substantially Equivalent	Zimmer, Inc.
K820289	ANTHROSCOPIC SURGICAL TABLE	Apr 21, 1982	Substantially Equivalent	The Anspach Effort, Inc.
K820291	KNEE SUPPORT FOR X-RAY & SURGERY	Mar 05, 1982	Substantially Equivalent	The Anspach Effort, Inc.
K813030	O.R. ARMBOARD COVER	Jan 18, 1982	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K810433	LOWER EXTREMITY SUPPORT SYSTEM-LESS	Mar 13, 1981	Substantially Equivalent	Walgen Medical Innoventions
K802558	SURCAN KNEE HOLDING DEVICE	Oct 31, 1980	Substantially Equivalent	Bend Orthopedic & Fracture Clinic
K801572	SURG-ASSIST	Aug 04, 1980	Substantially Equivalent	Medmetric Corp.
K790674	THE SURGICAL ASSISTANT	May 14, 1979	Substantially Equivalent	Instrument Makar, Inc.
K760456	TABLE, HAND SURGI	Nov 02, 1976	Substantially Equivalent	Stryker Corp.